ID

10639

Description

CALGB: 49903 ADVERSE EVENT FORM NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

Keywords

Versions (2)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB: 49903 ADVERSE EVENT FORM NCT00053339

English

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms  
CALGB clinical trial administrative data
Description

CALGB clinical trial administrative data

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

From
Description

CTCAdverseEventReportBeginDate

Data type

date

To (M)
Description

CTCAdverseEventReportEndDate

Data type

date

Amended data?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient demographics
Description

Patient demographics

Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

AffiliateName

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

ADR Report
Description

ADR Report

Was an ADR Report filed based on an event reported below?
Description

ADRFiledInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25410
UMLS 2011AA ObjectClass
C1521800
NCI Thesaurus Property
C25175
UMLS 2011AA Property
C1522646
Expected Adverse Events
Description

Expected Adverse Events

IMT Code
Description

IMTCodeduplicate

Data type

text

CTC Adverse Event Term
Description

CTCAdverseEventTerm

Data type

text

CTC Grade (Coding Instructions: Use the most current version of the NCI Common Toxicity Criteria CTC to determine the grade for each event with the exception of Hand-foot syndrome see protocol section 12.8. If no adverse event is reported for a specific category, code grade = 0. DO NOT USE THE CALGB EXPANDED COMMON TOXICITY CRITERIA.)
Description

CTCAdverseEventGrade

Data type

text

Attribution (Attribution Codes)
Description

CTCAdverseEventAttributionCode

Data type

text

Person Completing Form
Description

Person Completing Form

Completed By (Print or Type Name)
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Completed
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Calgb: 49903 Adverse Event Form
Description

Ccrr Module For Calgb: 49903 Adverse Event Form

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Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
CTCAdverseEventReportBeginDate
Item
From
date
CTCAdverseEventReportEndDate
Item
To (M)
date
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient demographics
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
AffiliateName
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
Item Group
ADR Report
Item
Was an ADR Report filed based on an event reported below?
text
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
CL.2
Code List
Was an ADR Report filed based on an event reported below?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Expected Adverse Events
IMTCodeduplicate
Item
IMT Code
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Grade (Coding Instructions: Use the most current version of the NCI Common Toxicity Criteria CTC to determine the grade for each event with the exception of Hand-foot syndrome see protocol section 12.8. If no adverse event is reported for a specific category, code grade = 0. DO NOT USE THE CALGB EXPANDED COMMON TOXICITY CRITERIA.)
text
Item
Attribution (Attribution Codes)
text
CL.3
Code List
Attribution (Attribution Codes)
CL Item
Unrelated (unrelated to treatment)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely to be related to treatment)
CL Item
Possibly (possible related to treatment)
CL Item
Probably (probably related to treatment)
CL Item
Definitely (definitely related to treatment)
Item Group
Person Completing Form
PersonCompletingForm,FirstName
Item
Completed By (Print or Type Name)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date Completed
date
Item Group
Ccrr Module For Calgb: 49903 Adverse Event Form
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